Electronic Muscle Stimulator (Model MP01)

K233035 · Shenzhen Hengbosi Industrial Co., Ltd. · NGX · Jan 8, 2024 · Physical Medicine

Device Facts

• Record ID: K233035
• Device Name: Electronic Muscle Stimulator (Model MP01)
• Applicant: Shenzhen Hengbosi Industrial Co., Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.

Device Story

Electronic Muscle Stimulator (Model: MP01) is an over-the-counter device for muscle strengthening and toning. Device delivers electrical pulses to muscles via electrodes to induce contraction; intended for abdominal, arm, and leg muscle groups. User operates device to select stimulation parameters; output affects muscle tone and firmness through repetitive contraction. Benefits include improved muscle definition and strength. Device is intended for home use by consumers.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; intended for abdominal, arm, and leg muscle groups. Class II device (21 CFR 890.5850).

Indications for Use

Indicated for individuals seeking improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of arms and legs. Over-the-counter use.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Hengbosi Industrial Co., Ltd. Zhiwei Chen General Manager 1035 Chuangke Building, No.72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District Shenzhen, Guangdong 518000 China

Re: K233035

Trade/Device Name: Electronic Muscle Stimulator (Model: MP01) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 23, 2023 Received: September 25, 2023

Dear Zhiwei Chen:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K233035

Device Name Electronic Muscle Stimulator (Model: MP01)

Indications for Use (Describe)

Electronic Muscle Stimulator is indicated to be used for:

Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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